Course Description

Risk Management has emerged in regulated industry as a recognized and accepted method of prioritizing and focusing activities and resources on quality issues that represent the greatest risk to the end user. From a business perspective, risk management tools also provide management with clear identification of high risk issues and a documented justification for focusing resources on issues of greatest importance, thus reducing waste and ineffectivity.

This workshop will focus on methods to imbed risk management concepts into elements of the quality systems and utilize current quality data to develop a closed-loop and “living” risk management program. The workshop will include discussion of the primary risk management tools and application of risk management controls to identify, evaluate, and mitigate risks. Use of risk management concepts in quality system elements such as design controls, complaints, nonconformances, use of trending tools, and escalation into CAPA will be discussed and will include best practices to integrate these processes to obtain consistent and defendable risk-based decisions.

Who Should Attend

Quality Unit professionals and others responsible for development and maintenance of quality systems

Prerequisites

Attendees should read ISO 14971:2007 prior to course attendance.

Learning Objectives

Upon completion of this course, you will be able to:

• Define basic risk management terminology
• Describe at least two risk analysis tools and their basic use
• Identify quality systems that are most applicable to use of risk management tools
• Develop an action plan to either implement or enhance the use of risk management tools in their company

Instructor

Lisa Hornback, Principal Consultant, Hornback Consulting, LLC

Class Schedule

Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. TRI will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 7:30 a.m. Lunch will be provided from 12:00 – 1:00 p.m. Snacks will be provided during the morning break from 10:00 – 10:15 a.m. and the afternoon break from 2:30 – 2:45 p.m.

Continuing Education Credits

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

Registration Fees

Member/Nonmembers Standard	$1295
Student/Academic/Government	$780

Rates in US dollars.

Location/Lodging Information

GRAND HYATT DENVER
1750 Welton Street
Denver, Colorado, USA 80202
Tel: +1 303 295 1234